BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, LOOP

    MDR report key: 16628847 · Received March 28, 2023

    Report

    Report Number
    9610773-2023-00890
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    February 19, 2023
    Report Date
    May 23, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761051689
    PMA / PMN Number
    K100275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H10: THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT IS LIKELY THE REPORTED EVENT OCCURRED DUE TO WEAR AND TEAR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K120418. MODEL: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE, 12 PCS., FOR TURIS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A RESECTION ELECTRODE HAD A BROKEN DISTAL END (LOOP). THE REPORTED PROBLEM WAS FOUND DURING USE FOR A PROSTATE RESECTION PROCEDURE. THE FACILITY FINISHED THE PROCEDURE WITH A DIFFERENT LOOP. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427033 HF-RESECTION ELECTRODE, LOOP ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22306D 1000079397 14042761051689

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown